Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis

NCT05572567 | Completed Results

• 1 other identifier: A3921429
• Study Type: observational
• Target: 1,972
• Locations: 1 country
• Sites: 1

Brief Summary

This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry. The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (15)

• Mean Incidence Rate of Total Cardiovascular Disease (CVD) Events

  Incidence rate was defined as participants with total CVD events per (/) 100 person years. Total CVD was defined as hypertension requiring hospitalization, cardiac revascularization procedure (CABG, stent, angioplasty), ventricular arrhythmia, cardiac arrest, myocardial infarction, acute coronary syndrome, unstable angina, congestive heart failure (CHF) requiring hospitalization, stroke, transient ischemic attack, other cardiovascular event (specify), deep vein thrombosis, peripheral arterial thromboembolic event, urgent peripheral arterial revascularization, peripheral ischemia or gangrene (necrosis) and pulmonary embolism. Index visit was defined as the initiation date of the therapy of interest. Mean of incidence rate of total CVD events was calculated and reported.

  Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

• Mean Incidence Rate of Serious Infections Events

  Incidence rate was defined as mean number of participants with serious infection events per 100 person years. Total serious infections were defined as infections meeting serious adverse event criteria or which required treatment with intravenous (IV) antibiotics. Serious infection types collected in the registry were pneumonia, sepsis, joint/bursa, cellulitis/skin, sinusitis, diverticulitis, bronchitis, gastroenteritis, meningitis/encephalitis, urinary tract infection, upper respiratory infection, active tuberculosis and other serious infections. Mean of incidence rate of total serious infection events was calculated and reported.

  Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

• Mean Incidence Rate of Total Herpes Zoster Events

  Incidence rate was defined as mean number of participants with total Herpes Zoster events per 100 person years. Total herpes zoster included both serious and non-serious herpes zoster events. Mean of incidence rate of total herpes zoster events was calculated and reported.

  Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

• Mean Incidence Rate of Total Malignancy Excluding Non-Melanoma Skin Cancer (NMSC)

  Incidence rate (number of participants with event per 100 person year) was defined as the mean number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Total malignancy excluding non-melanoma skin cancer included lymphoma, lung cancer, breast cancer, skin cancer (melanoma), and other cancers. Mean of incidence rate of total malignancy excluding non-melanoma skin cancer was calculated and reported.

  Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

• Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at 6 Months

  CDAI was the numerical sum of four outcome parameters: Tender joint count (TJC) or swollen joint count (SJC) both based on a 28-joint assessment, participant's assessment (PtGA) of disease activity and physician's global assessment (PGA) of disease activity both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicated greater affection due to disease activity). CDAI total score ranged from 0 to 76. Higher scores indicated greater affection due to disease activity. CDAI less than or equal to (\<=) 2.8 indicated disease remission, greater than (\>) 2.8 to 10 indicated low disease activity, \>10 to 22 indicates moderate disease activity, and \>22 indicated high disease activity. Mean change from baseline was calculated by subtracting the baseline value from the 6-month value.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Mean Change From Baseline in Japanese Health Assessment Questionnaire (J-HAQ) at 6 Months

  HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. Higher scores indicated worse functioning. Mean change from baseline was calculated by subtracting the baseline value from the 6-month value.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Mean Change From Baseline in Participant's Pain at 6 Months

  Participants were asked the following question to answer on a numeric rating scale (NRS): "How much pain have you had because of your arthritis in the past week?" The scale ranged from 0-100, where 0=no pain and 100=pain as bad as it could be. Higher scores indicated worsening of condition. Mean change from baseline in participant's pain was calculated and reported.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Mean Change From Baseline in Participant's Fatigue at 6 Months

  Visual Analogue Scale (VAS) was a standardized tool for measuring overall health. Participants recorded their fatigue score on a range of 0 to 100, where higher score indicated higher intensity of fatigue. Mean change from baseline in participant's fatigue was calculated and reported.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Mean Change From Baseline in Participant's Global Assessment at 6 Months

  Participant's global assessment of disease activity on a 100 millimeter (mm) Visual Analog Scale (VAS) (scores ranging from 0 mm \[very well\] to 100 mm \[worst\], higher scores indicated worse health condition). Mean change from baseline was calculated by subtracting the baseline value from the 6-month value.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Mean Change From Baseline in Morning Stiffness at 6 Months

  CDAI and other continuous measures like morning stiffness were represented as mean change from baseline to 6-months and were calculated by subtracting the baseline value from the 6-month value.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Change in Percentage of Participants Reporting Moderate/Severe/Extreme Difficulty Levels for EQ-5D-5L From Baseline at Month 6

  EQ-5D-5L was a participant rated questionnaire to assess health-related quality of life. It assessed level of current health in 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each domain had 5 levels: 1= no problems, 2=slight problems, 3=moderate problems, 4=severe problems, or 5=extreme problems/unable to do task. Total score for each domain was from 1-5, where higher levels/scores indicated more difficulty in each domain. At baseline and 6 months, percentage of participants who recorded "moderate", "severe" or "extreme problems" level in each of the domain were assessed; then change was calculated in percentage of participants from baseline at Month 6 and was reported in this outcome measure.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Percentage of Participants Who Achieved Minimally Clinically Important Difference (MCID) Improvement at 6 Months

  MCID improvement assessed based on CDAI. CDAI: numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; CDAI total score = 0-76, higher scores=greater affection due to disease activity (DA). CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low DA, \>10 to 22 = moderate DA, and \>22 = high DA. MCID improvement defined by difference in CDAI from baseline (at time of tofacitinib initiation) to 6-month visit.

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Percentage of Participants Who Achieved Modified American College of Rheumatology (mACR) 20 Response Score at 6 Months

  mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the j-HAQ (scored from 0 to 3, higher scores indicated worsening of function).

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Percentage of Participants Who Achieved mACR 50 Response Score at 6 Months

  mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the j-HAQ (scored from 0 to 3, higher scores indicated worsening of function).

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

• Percentage of Participants Who Achieved mACR 70 Response Score at 6 Months

  mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the j-HAQ (scored from 0 to 3, higher scores indicated worsening of function).

  Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

Study Arms (1)

Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs

to include all Japanese patients taking Tofacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in an existing registry database

You may qualify if:

• Diagnosed with Rheumatoid Arthritis (RA) according to the 1987 American College of Rheumatology (ACR) or the ACR/European Lead Against Rheumatism (EULAR) 2010 RA Classification Criteria;
• At least 18 years of age or older;
• Was / Must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit:
• csDMARD: methotrexate (closed in February 2018);
• Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-TNF biosimilar approved during the study;
• Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020);
• JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib.

You may not qualify if:

• Data that are prior to March 2016 and after June 2022

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Publications (1)

• Tanaka Y, Kishimoto M, Sonomoto K, Amano K, Harigai M, Onofrei A, O'Brien J, Margolin Z, Barr C, Mizuno Y, Agarwal E, Sugiyama N, Yamanaka H. Methotrexate, Tofacitinib, and Biologic Disease-Modifying Antirheumatic Drug Safety and Effectiveness Among Patients with Rheumatoid Arthritis in Japan: CorEvitas Registry Observational Study. Rheumatol Ther. 2024 Oct;11(5):1237-1253. doi: 10.1007/s40744-024-00700-2. Epub 2024 Jul 27.

  PMID: 39066962 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: October 10, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)